EP 3203984 A1 20170816 - PHARMACEUTICAL COMPOSITION CONTAINING BUDESONIDE AND FORMOTEROL.
Title (en)
PHARMACEUTICAL COMPOSITION CONTAINING BUDESONIDE AND FORMOTEROL.
Title (de)
PHARMAZEUTISCHE ZUSAMMENSETZUNG MIT BUDESONID UND FORMOTEROL
Title (fr)
COMPOSITION PHARMACEUTIQUE CONTENANT DU BUDÉSONIDE ET DU FORMOTÉROL
Publication
Application
Priority
- IT MI20141762 A 20141008
- EP 2015073190 W 20151007
Abstract (en)
[origin: WO2016055546A1] The present invention relates to inhalation formulations of drugs in the form of dry powder for inhalation administration, suitable for the treatment of obstructive diseases of the airways, such as asthma and chronic obstructive pulmonary disease (COPD). In particular, the invention relates to a pharmaceutical composition for inhalation comprising a first powder comprising budesonide or a pharmaceutically acceptable salt thereof, in an amount greater than 5% by weight of said first powder, leucine in an amount from 5 to 70% by weight of said first powder, lactose in an amount from 20 to 90% by weight of said first powder; a second powder comprising formoterol or a pharmaceutically acceptable salt thereof, in an amount greater than 1% by weight of said second powder, leucine in an amount from 5 to 70% by weight of said second powder, lactose in an amount from 20 to 90% by weight of said second powder and a third powder comprising a mixture of a first lactose which has an X50 from 3 to 75 µm, with a second lactose which has an X50 from 1.5 to 10 µm, the content of said first and second lactose in said mixture being respectively from 85% to 96% and from 4% to 15%. Said composition has a fine particle fraction (FPF) greater than 60% and a delivered fraction (DF) greater than 80%.
IPC 8 full level
A61K 9/00 (2006.01); A61K 9/16 (2006.01); A61K 31/167 (2006.01); A61K 31/58 (2006.01)
CPC (source: CN EA EP IL KR US)
A61K 9/0075 (2013.01 - CN EA EP IL KR US); A61K 9/1617 (2013.01 - CN EA EP IL KR US); A61K 9/1623 (2013.01 - CN EA EP IL KR US); A61K 31/167 (2013.01 - CN EA EP IL KR US); A61K 31/58 (2013.01 - CN EA EP IL KR US); A61P 11/00 (2018.01 - EA EP IL); A61P 11/06 (2018.01 - EA EP IL); A61P 43/00 (2018.01 - EA EP IL); A61K 2300/00 (2013.01 - EA IL KR)
C-Set (source: CN EP US)
CN
EP US
Designated contracting state (EPC)
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
Designated extension state (EPC)
BA ME
DOCDB simple family (publication)
WO 2016055546 A1 20160414; AU 2015330012 A1 20170525; AU 2021200396 A1 20210318; AU 2021200396 B2 20230209; BR 112017007142 A2 20171219; CA 2963445 A1 20160414; CA 2963445 C 20230718; CN 107205958 A 20170926; CN 115844860 A 20230328; CO 2017004512 A2 20171020; EA 035755 B1 20200805; EA 201700183 A1 20171031; EP 3203984 A1 20170816; EP 3203984 B1 20240117; ES 2971768 T3 20240606; IL 251478 A0 20170529; IL 251478 B 20210630; JP 2017530987 A 20171019; JP 6684275 B2 20200422; KR 102449403 B1 20220929; KR 20170086489 A 20170726; MX 2017004583 A 20171120; MY 191295 A 20220614; US 10449147 B2 20191022; US 2017326067 A1 20171116
DOCDB simple family (application)
EP 2015073190 W 20151007; AU 2015330012 A 20151007; AU 2021200396 A 20210121; BR 112017007142 A 20151007; CA 2963445 A 20151007; CN 201580066146 A 20151007; CN 202211603766 A 20151007; CO 2017004512 A 20170504; EA 201700183 A 20151007; EP 15784294 A 20151007; ES 15784294 T 20151007; IL 25147817 A 20170330; JP 2017518998 A 20151007; KR 20177012308 A 20151007; MX 2017004583 A 20151007; MY PI2017701182 A 20151007; US 201515517672 A 20151007